Events

Recall of Device Recall Faaborg Person Lift, Solution/Nordic Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Moving Solutions, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28199
  • Event Risk Class
    Class 1
  • Event Number
    Z-0553-04
  • Event Initiated Date
    2004-01-21
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31388
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Reason
    Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
  • Action
    Letters were sent to all Faaborg lift customers on 11/29/01 and 01/24/04 advising the users that all bolts in connection with the hanger bar must be inspected, greased and tightened, and all defective or worn down bolts and washers must be changed. The 1/24/04 letters included an upgraded maintenance schedule and an Important Service/Safety Reminder, as well as a supply of hanger bar bolt washers. Any questions were directed to Moving Solutions' Service Department at 800-228-7980. Follow-up letters were sent to the accounts on 3/11/04, referencing the 1/21/04 letter and instructing the accounts not to use the lifts until the bolts have been inspected and retrofitted with the washers. Copies of the revised maintenance schedule and operating instructions were included.

Device

Device Recall Faaborg Person Lift, Solution/Nordic Series
  • Model / Serial
    all Solution/Nordic series models, all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to nursing homes, residential schools and home patients, and internationally to Canada.
  • Product Description
    Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic series lifts have electric V-shape base widening, with a weight capacity of 210 lbs. to 365 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.
  • Manufacturer
    Moving Solutions, Inc.

Manufacturer

Moving Solutions, Inc.
  • Manufacturer Address
    Moving Solutions, Inc., 2550 Wisconsin Ave, Downers Grove IL 60515
  • Source
    USFDA